HIV/STI Prevention for Drug-Involved Couples (Connect II)

This study has been completed.
Sponsor:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT01285349
First received: January 21, 2011
Last updated: January 26, 2011
Last verified: January 2011
  Purpose

This randomized controlled trial is designed to address gaps in couple-based HIV prevention research by focusing exclusively on HIV negative concordant couples where one or both partners are drug-involved. Building on prior couple-based HIV research that resulted in an evidence-based HIV prevention model for couples (Connect), intervention components were modified to address dyadic drug risk reduction and drug-related unsafe sex and a couple-based HIV risk reduction intervention (Connect II) was designed specifically for drug-involved, HIV negative concordant heterosexual couples at risk for HIV/STIs. For this RCT, couples are recruited primarily through street outreach in drug using locations and randomized into one of three arms: (1) couple-based HIV Risk Reduction condition; (2) individual-based HIV Risk Reduction, which delivered the same content as the couple-based condition but was provided to either the male or female drug-using partner alone; or (3) couple-based Wellness Promotion, which served as an attentional control arm. This RCT tests two major hypotheses: (1) whether the HIV risk reduction intervention provided to the couple or an individual partner would be more efficacious in decreasing number of unprotected acts of intercourse and having a lower cumulative incidence of biologically confirmed STIs over the 12-month follow-up period compared to the Wellness promotion control arm and (2) whether the couple-based HIV risk reduction intervention would be more likely to decrease the number of unprotected acts and have a lower cumulative STI incidence compared to the Individual HIV Risk reduction Arm.


Condition Intervention Phase
Sexually Transmitted Diseases
Behavioral: Couple HIV/STI prevention intervention
Behavioral: Couple-based HIV prevention
Behavioral: Individual HIV/STI prevention
Behavioral: Couple Wellness Promotion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: HIV/STI Prevention for Drug-Involved Couples

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • number of unprotected acts of intercourse [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea, and Trichomoniasis [ Time Frame: past 12 months ] [ Designated as safety issue: No ]

Enrollment: 564
Study Start Date: November 2005
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Couple-based HIV prevention Behavioral: Couple HIV/STI prevention intervention Behavioral: Couple-based HIV prevention
Active Comparator: Individual HIV/STI Prevention Behavioral: Individual HIV/STI prevention
Active Comparator: Couple Wellness Promotion Behavioral: Couple Wellness Promotion

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Couples were eligible to participate if:

  • Both were 18 and older and at least one partner was 18-40
  • Both tested HIV negative using Oratest procedures
  • Both identified each other as main, regular partner, boy/girlfriend, spouse, lover
  • Both reported that they have been together for at least 6 months
  • Both intended to remain together for at least one year
  • At least one partner reported using illicit drugs in the prior 90 days and was seeking or in drug treatment
  • At least one partner reported having had unprotected intercourse with the other in the prior 90 days.

Additionally, at least one partner had to report one or more of the following HIV risk criteria:

  • Having had sex with other partners in the prior 90 days
  • Injecting drugs in the prior 90 days; or
  • Self-report being diagnosed with an STI in the prior 90 days.

Exclusion Criteria:

Couples were excluded from the study:

  • If either partner reported experiencing severe intimate partner violence in the past year by the other partner as assessed by subscales of the Revised Conflict Tactics Scale
  • If either partner exhibited a severe cognitive or psychiatric impairment assessed during informed consent
  • If either partner did not have sufficient understanding of English
  • If either partner reported intentions to have a baby in the next year and to relocate beyond a reasonable distance from the study site in the coming year.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285349

Locations
United States, New York
Social Intervention Group/Columbia University School of Social Work
New York, New York, United States, 10027
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Louisa Gilbert, PhD Columbia University
  More Information

No publications provided

Responsible Party: Louisa Gilbert, Social Intervention Group at Columbia University
ClinicalTrials.gov Identifier: NCT01285349     History of Changes
Other Study ID Numbers: AAAA6653
Study First Received: January 21, 2011
Last Updated: January 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
HIV, STI, condom use, drug use,

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 02, 2014